Zuhera Use In Pregnancy & Lactation

Pregnancy: It is not known whether Trastuzumab can harm the foetus when administered to a pregnant woman or whether it can affect reproductive capacity. Animal reproduction studies done with Trastuzumab revealed no evidence of impaired fertility or harm to the foetus. Avoid administering Zuhera to pregnant women, unless the potential benefit for the mother outweighs the potential risk to the foetus. Oligohydramnios, and cases of impaired foetal renal growth and/or function in association with oligohydramnios (some associated with fatal pulmonary hypoplasia of the foetus), skeletal abnormalities and neonatal death have been reported in pregnant women receiving Trastuzumab. Advise women of childbearing potential to use effective contraception during treatment with Zuhera; and for at least 7 months thereafter. Women who become pregnant should be informed that harm to the foetus is possible. If a pregnant woman is treated with Zuhera, close monitoring by a multidisciplinary team is desirable. Monitor women exposed to Trastuzumab during pregnancy for oligohydramnios. At doses up to 25 times the weekly human maintenance dose of 2 mg/kg, no evidence of impaired fertility or harm to the foetus was seen in cynomolgus monkey reproductive studies with Trastuzumab. Embryonic death was seen in mutant mice lacking HER2 receptor. In cynomolgus monkeys, placental transfer of Trastuzumab during the early (days 20-50 of gestation) and late (days 120-150 of gestation) foetal development was observed.
Lactation: Breast-feeding should be avoided during Zuhera therapy. Human IgG is secreted into human milk; and the potential for harm to the infant is unknown. There is no information on whether Trastuzumab is secreted in human milk. Women should not breast-feed during Zuhera therapy and for 7 months after the last dose. In cynomolgus monkeys, Trastuzumab was found to be secreted in milk at doses up to 25 times that of the weekly human maintenance dose of 2 mg/kg. However, no adverse effects on their growth or development from birth to 1 month were associated with the presence of Trastuzumab in the serum of infant monkeys.